US11104960B2ActiveUtilityA1

Detecting esophageal disorders

96
Assignee: EXACT SCIENCES DEV CO LLCPriority: Mar 27, 2015Filed: Sep 13, 2019Granted: Aug 31, 2021
Est. expiryMar 27, 2035(~8.7 yrs left)· nominal 20-yr term from priority
G01N 33/57557C12Q 2600/166G01N 2800/14G01N 2440/12C12Q 2600/154C12Q 2600/112C12Q 1/6886C12Q 1/6883G01N 33/57407
96
PatentIndex Score
6
Cited by
273
References
4
Claims

Abstract

Provided herein is technology for esophageal disorder screening and particularly, but not exclusively, to methods, compositions, and related uses for detecting the presence of esophageal disorders (e.g., Barrett's esophagus, Barrett's esophageal dysplasia, etc.). In addition, the technology provides methods, compositions and related uses for distinguishing between Barrett's esophagus and Barrett's esophageal dysplasia, and between Barrett's esophageal low-grade dysplasia, Barrett's esophageal high-grade dysplasia, and esophageal adenocarcinoma within samples obtained through endoscopic brushing or nonendoscopic whole esophageal brushing or swabbing using a tethered device (e.g. such as a capsule sponge, balloon, or other device).

Claims

exact text as granted — not AI-modified
We claim: 
     
       1. A method comprising:
 extracting genomic DNA from a biological sample of a human individual suspected of having or having gastro-intestinal neoplasm, 
 treating the extracted genomic DNA with bisulfite, 
 amplifying the bisulfite-treated genomic DNA using primers specific for no more than ten markers, wherein the no more than ten markers include either ZNF682 or ZNF682 and NDRG4, 
 measuring the methylation level of the CpG site for the markers by methylation-specific PCR, quantitative methylation-specific PCR, methylation-sensitive DNA restriction enzyme analysis, or bisulfite genomic sequencing PCR. 
 
     
     
       2. The method of  claim 1 , wherein one of the no more than ten markers is VAV3. 
     
     
       3. The method of  claim 1 , wherein the biological sample comprises cells, tissues, and/or secretions from the upper gastrointestinal tract and/or the lower gastrointestinal tract. 
     
     
       4. The method of  claim 1 , wherein the biological sample is a stool sample, a tissue sample, a blood sample, or a urine sample.

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